BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEW POLIGRIP SA

    MDR report key: 2464112 · Received February 16, 2012

    Report

    Report Number
    9681138-2012-00028
    Event Type
    Other
    Date Received
    February 16, 2012
    Date of Event
    September 1, 2011
    Report Date
    February 13, 2012
    Manufacturer
    GLAXOSMITHKLINE
    Product Code
    KOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER'S REPORT NUMBER FOR THIS CASE IS 9681138-2012-00028. NEW POLIGRIP SA IS MANUFACTURED IN (B)(4), AND MARKETED UNDER THE TRADE NAME SUPER POLIGRIP ORIGINAL IN THE UNITED STATES. THE PRODUCT WAS NOT AVAILABLE, (B)(4).

    Description of Event or Problem · 1

    THIS CASE WAS REPORTED BY A CONSUMER (PATIENT'S HUSBAND) AND DESCRIBED THE OCCURRENCE OF LOSS OF CONSCIOUSNESS IN A FEMALE PATIENT WHO RECEIVED DOUBLE SALT DENTAL ADHESIVE CREAM (NEW POLIGRIP SA) FOR A PARTIAL ARTIFICIAL TOOTH. A PHYSICIAN OR OTHER HEALTH CARE PROFESSIONAL HAS NOT VERIFIED THIS REPORT. CONCURRENT MEDICAL CONDITIONS INCLUDED DIABETES MELLITUS. CONCURRENT MEDICATIONS INCLUDED UNSPECIFIED DIABETES MEDICATION. THE PATIENT VISITS THE HOSPITAL ON A MONTHLY BASIS. ON AN UNKNOWN DATE, APPROXIMATELY 2 YEARS AGO, THE PATIENT STARTED USING DOUBLE SALT DENTAL ADHESIVE CREAM AT AN UNKNOWN DOSE. ON AN UNKNOWN DATE, IN (B)(6) 2011, THE PATIENT HAD A FULL ARTIFICIAL TOOTH AND USED DOUBLE SALT DENTAL ADHESIVE CREAM. AT THAT TIME, THE PATIENT EXPERIENCED THIRST AND DRANK 4 LITRES OF WATER IN SOME CASES (EXCESSIVE DRINKING). WHEN THE PATIENT DID NOT USE DOUBLE SALT DENTAL ADHESIVE CREAM THE THIRST DID NOT OCCUR. ON AN UNKNOWN DATE, AT THE END OF 2011 OR BEGINNING OF 2012, THE PATIENT HAD SEVERE THIRST AND DRANK A LOT OF WATER. AFTERWARDS THE PATIENT EXPERIENCED LOSS OF CONSCIOUSNESS. A DEVICE FAILURE WAS REPORTED. THE CASE WAS ASSESSED AS CLINICALLY SIGNIFICANT (OR REQUIRING INTERVENTION). ON (B)(6) 2012, AFTER THE PATIENT DRANK A LOT OF WATER, LOSS OF CONSCIOUSNESS OCCURRED WHILE IN A SHOPPING DISTRICT. AT THE TIME OF REPORTING, THE EVENTS WERE UNRESOLVED AND THE PATIENT WAS SLEEPING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEW POLIGRIP SA DOUBLE SALT DENTAL ADHESIVE CREAM KOL GLAXOSMITHKLINE NA IB1183

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention DIABETES MEDICATION: (UNK - UNK)